Devices for image-guided light treatment of skin

ABSTRACT

In one aspect, devices for light treatment of skin are described herein. A device described herein, in some embodiments, comprises an interior compartment having a proximal end and a distal end, and an optical aperture disposed at the distal end. The device also comprises a laser or BBL source that produces a laser or BBL beam. The laser or BBL beam has a first optical path within the interior compartment, between the proximal end and the distal end. Additionally, the first optical path exits the interior compartment through the optical aperture. The device further comprises an imaging system that receives a return signal from the aperture. The return signal received from the aperture has a second path within the interior compartment. Further, a selectively reflective optical element is disposed in the first and second optical paths. The selectively reflective optical element generally transmits the laser or BBL beam.

CROSS REFERENCE TO RELATED APPLICATIONS

This application is the national stage application under 35 U.S.C. § 371of International Application No. PCT/US2017/017574, filed on Feb. 11,2017, which claims priority pursuant to 35 U.S.C. § 119 to U.S.Provisional Patent Application Ser. No. 62/294,915, filed on Feb. 12,2016, each of which is hereby incorporated by reference in its entirety.

FIELD

This invention relates to devices and methods for treating skin and, inparticular, to devices and methods for the treatment of skin with light,such as laser light or Intense Pulsed Light (IPL).

BACKGROUND

Many skin conditions can be treated with lasers. In general, laser lightis selectively delivered to specific areas of the skin in such treatmentmethods. Selective and precise delivery of laser light to a specificarea of skin can improve safety, increase treatment efficacy, andminimize adverse, undesired effects of treatment. However, in manytreatments, target areas of skin are very small. For example, in somecases, target areas of skin have dimensions of less than one millimeter.Thus, laser treatment of skin often requires microscopically precisetargeting of laser light. Unfortunately, many current laser treatmentdevices are not capable of such precise delivery of laser light to skin.There is accordingly a need for improved devices and methods forprecisely delivering laser light to desired areas of skin.

In hyperhidrosis, an excess of sweating is observed in certain areas ofthe skin, including in the axilla, on the palms of the hands, and on thesoles of the feet. One common way to address hyperhidrosis is the use ofdeodorants and/or antiperspirants. However, the action or effectivenessof deodorants and antiperspirants are often limited to several hours.Other existing treatment methods of hyperhidrosis include surgicalremoval of sweat glands from under the skin, application of a botulinumtoxin, or destruction of sweat pores by the application ofelectromagnetic radiation in the microwave region of the spectrum. Whilethese techniques can be effective in certain cases, these techniques canalso suffer from one or more disadvantages. For example, the use of abotulinum toxin is currently not cleared for palms and soles, andtreatment with a botulinum toxin provides only temporary relief ofsymptoms. As another example, the use of microwave radiation isassociated with high tissue morbidity. Thus, there is a need forimproved devices and methods for treating various skin conditions suchas hyperhidrosis or unwanted hair, including in a manner that is safe,efficient, and/or permanent.

SUMMARY

In one aspect, devices and methods for treating skin are describedherein which, in some cases, can provide one or more advantages comparedto some other devices and methods. For example, in some embodiments, adevice described herein can enable the precise delivery of laser lightor other light to a desired region of skin or other target surface.Additionally, in some embodiments, a method described herein can treat avariety of skin conditions through the precise targeting and/ordestruction of various skin components, such as eccrine glands or hairfollicles. Moreover, devices and methods described herein can combinelaser or other light delivery with skin imaging in a single deviceand/or process. Additionally, in some cases, a method or devicedescribed herein provides automated visual identification of skintreatment targets followed by computer- and opto-mechanically-guidedlight treatment of the identified targets. Methods and devices describedherein can also provide safe, efficient, and/or permanent treatment ofvarious skin conditions or diseases.

In one aspect, devices for the light treatment of skin (or other targetsor surfaces) are described herein. In some embodiments, such a devicecomprises an interior compartment having a proximal end and a distalend, and an optical aperture disposed at the distal end. The device alsocomprises a laser or Broad Band Light (BBL) source that produces or ispositioned or configured to produce a laser or BBL beam. As describedfurther below, the BBL source can be produced from an intense flashlampderived incoherent light beam, which is sometimes called Intense PulsedLight (IPL). For reference purposes herein, the term “BBL” will be usedto refer to BBL and IPL, such that the two terms are interchangeable.The laser or BBL beam has a first average wavelength and a first opticalpath within the interior compartment of the device, between the proximalend and the distal end of the device. Additionally, the first opticalpath of the laser or BBL beam exits the interior compartment of thedevice through the optical aperture. In some cases, a device describedherein can also comprise a light source that illuminates an areatargeted and/or imaged by the device. Moreover, the device furthercomprises an imaging system, such as a camera or other imaging system.The imaging system receives a return signal (such as light), or ispositioned or configured to receive a return signal, from or through theoptical aperture. In some cases, the return signal received from orthrough the optical aperture has a second average wavelength and asecond optical path within the interior compartment of the device. Thesecond average wavelength of the return signal received from or throughthe optical aperture generally differs from the first average wavelengthof the laser or BBL beam. The first optical path of the laser or BBLbeam also generally differs, at least in part, from the second opticalpath of the return signal received by the imaging system from or throughthe optical aperture of the device. In addition, a device describedherein further comprises a selectively reflective optical element, suchas a selectively reflective plate. The selectively reflective opticalelement is disposed in both the first optical path and also in thesecond optical path. Moreover, the selectively reflective opticalelement transmits at least 70% of the total intensity of the laser orBBL beam incident on the selectively reflective optical element, or isat least 70% transparent to the first average wavelength of the laser orBBL beam. Additionally, the selectively reflective optical element alsoreflects to the imaging system at least a portion of the incident returnsignal received from the optical aperture. More particularly, theselectively reflective optical element can reflect to the imaging systema sufficient amount of incident return signal received from the apertureto permit the imaging system to receive, record, construct, and/orprocess an image from the reflected return signal. The image generallycorresponds to at least a portion of a targeted and/or imaged area ofskin or a surface of skin. In some cases, the selectively reflectiveoptical element reflects to the imaging system at least 1% of the totalintensity of incident return signal received from the optical aperture,or is at least 1% reflective to the second average wavelength of thereturn signal received from or through the optical aperture.

It is further to be understood that, in some embodiments, the imagingsystem is configured to send a query, probe, diagnostic, or forwardsignal, in addition to receiving a return signal. For instance, in somecases, the imaging system comprises a query beam generator that producesa query beam traveling along the second optical path. The imaging systemcan also comprise a return signal receiver that detects, receives, orprocesses the return signal. As described further hereinbelow, thereturn signal, in some cases, is a transformed or altered version of thequery beam. For example, in some instances, the imaging system is anoptical coherence tomography (OCT) system, the query beam comprises anOCT pilot beam, and the return signal comprises, consists, or consistsessentially of optical “echoes” of the pilot beam.

Moreover, in some cases, a device described herein further comprises anapplicator attached to the distal end of the interior chamber. Theapplicator is configured to couple, connect, or attach the device to asurface of skin of a patient, including for laser or BBL beam deliveryto the surface of skin and/or imaging of the surface of skin. In someembodiments, the applicator comprises a bottom surface adjacent to or indirect contact with the surface of skin, and the bottom surfacecomprises a window that is substantially transparent to the laser or BBLbeam and to the return signal received by the imaging system.Additionally, the bottom surface of the applicator can be substantiallyflat or planar. The bottom surface of the applicator may also beconformal to the surface of skin. Further, in some instances, the bottomsurface of the applicator comprises an adhesive for reversibly adheringthe bottom surface of the applicator to the surface of skin. Inaddition, in some embodiments, the applicator comprises a non-permeablechamber and the bottom surface of the applicator forms one or morehermetic seals with the surface of skin. The non-permeable chamber ofthe applicator may also be in fluid communication with a vacuum pump forsupplying a vacuum to an interior of the non-permeable chamber, therebypreventing or minimizing lateral movement of the device relative to thesurface of the skin being treated and/or imaged. Further, in some cases,the applicator tracks relative movement of the surface of skin of thepatient in one or more lateral directions relative to the opticalaperture of the device.

A device described herein can also comprise one or more additionalcomponents. For example, in some embodiments, a device described hereinfurther comprises computer hardware and/or software for identifying aspatial location of one or more structures, components, or constituentsof skin (where the terms “structures,” “components,” and “constituents”of skin can be used interchangeably) proximate the distal end of thedevice. The device may also comprise computer hardware and/or softwarefor identifying or determining a class or type, size, shape, color,estimated depth, and/or shaft angle of one or more skin constituents.Further, the hardware and/or software can comprise software forcorrecting and/or calibrating image non-linearities or distortions fromthe second optical path or discrepancies in a mechanical model usedduring image processing. Additionally, the computer hardware and/orsoftware can be mechanically and electrically coupled to the camera orother imaging system of the device, including for processing image dataand/or transmitting the image data for further processing, presentation,or display.

A device described herein may also include one or more lenses, mirrors,and/or actuators for directing the light received from the opticalaperture to the imaging system and/or for directing the laser or BBLbeam to one or more desired locations on a surface of skin of a patient.Additionally, computer hardware and/or software of a device describedherein can also be used to control the foregoing components so as todirect the laser or BBL beam to a desired location within a treatmentarea of the skin of the patient, as described further below.

In another aspect, methods of treating skin or structures, components,or constituents of skin with a laser or BBL source are described herein.In some cases, such a method comprises removing, destroying, ablating,vaporizing, or coagulating (which can collectively be referred to as“treating”) a specific structure, component, or constituent of skin of apatient, including in a specific treatment area targeted by or incontact with a device described herein. Additionally, in someembodiments, a treated structure or constituent of skin is visuallylabeled or imaged prior to removal or ablation. As described furtherhereinbelow, such labeling and imaging of a structure or constituent ofskin can permit precise treatment of skin. In some cases, a methoddescribed herein comprises applying a contrast agent to a treatment areaof skin of a patient to produce a labeled structure of the skin. Themethod further comprises detecting the labeled structure of the skin inan image of the treatment area, and using the image to applyelectromagnetic radiation to the labeled structure. However, in otherembodiments, a structure of skin can be imaged without the use of acontrast agent. In some such cases, one or more “native” or naturallyoccurring features of the skin structure are used to visually identifythe skin structure. Additionally, in some instances, the electromagneticradiation used in a method described herein is a laser or BBL beamproduced by a device described herein. It is to be understood that thelaser or BBL beam or other electromagnetic radiation is applied to thelabeled or unlabeled structure of the skin at a power and for a durationsufficient to remove, ablate, vaporize, destroy, coagulate, or otherwisetherapeutically treat the labeled or unlabeled structure of the skin, ora portion thereof. In this manner, the labeled or unlabeled structure ofthe skin can be removed, ablated, vaporized, destroyed, or otherwisetreated or rendered non-harmful to the patient, including within thetargeted treatment area of the skin. As described further hereinbelow,methods described herein can be used to treat various skin structures orconstituents and/or various skin-related disorders or conditions. Forexample, in some embodiments, a structure described herein is a pore,gland, hair follicle, acne, skin lesion (which may be benign,pre-malignant, or malignant), blood vessel, or vascular lesion. In somesuch cases, the gland is an eccrine sweat gland, apocrine gland,apoeccrine gland, or sebaceous gland.

These and other embodiments are described in more detail in the detaileddescription which follows.

BRIEF DESCRIPTION OF THE FIGURES

FIG. 1 is a schematic diagram of a device for laser treatment of skinaccording to one embodiment described herein.

FIGS. 2A and 2B are, respectively, plan and sectional views of a portionof a device for laser treatment of skin according to one embodimentdescribed herein.

FIG. 3 is a block diagram of an exemplary system for laser treatment ofskin according to some embodiments described herein.

FIG. 4 is a schematic diagram of a device for light treatment of skinaccording to one embodiment described herein.

DETAILED DESCRIPTION

Embodiments described herein can be understood more readily by referenceto the following detailed description, examples, and figures. Elements,apparatus, and methods described herein, however, are not limited to thespecific embodiments presented in the detailed description, examples,and figures. It should be recognized that these embodiments are merelyillustrative of the principles of the present invention. Numerousmodifications and adaptations will be readily apparent to those of skillin the art without departing from the spirit and scope of the invention.

In addition, all ranges disclosed herein are to be understood toencompass any and all subranges subsumed therein. For example, a statedrange of “1.0 to 10.0” should be considered to include any and allsubranges beginning with a minimum value of 1.0 or more and ending witha maximum value of 10.0 or less, e.g., 1.0 to 5.3, or 4.7 to 10.0, or3.6 to 7.9.

All ranges disclosed herein are also to be considered to include the endpoints of the range, unless expressly stated otherwise. For example, arange of “between 5 and 10” or “from 5 to 10” or “5-10” should generallybe considered to include the end points 5 and 10.

Further, when the phrase “up to” is used in connection with an amount orquantity, it is to be understood that the amount is at least adetectable amount or quantity. For example, a material present in anamount “up to” a specified amount can be present from a detectableamount and up to and including the specified amount.

I. Devices for Light Treatment of Skin

In one aspect, devices for the light treatment of skin (or other targetsor surfaces) are described herein. In some embodiments, such a devicecomprises an interior compartment having a proximal end and a distalend, and an optical aperture disposed at the distal end. The device alsocomprises a laser or BBL source that produces, or is positioned orconfigured to produce, a laser or BBL beam. The laser or BBL beam has afirst optical path within the interior compartment of the device,between the proximal end and the distal end of the interior compartment.Additionally, the first optical path of the laser or BBL beam exits theinterior compartment through the aperture. The device further comprisesan imaging system, such as a camera or other imaging system, thatreceives, or is positioned to receive, light or another return signalfrom the aperture. The return signal received from the aperturegenerally has a second optical path within the interior compartment. Inaddition, a device described herein, in some cases, further comprises aselectively reflective optical element disposed in both the firstoptical path and also in the second optical path. The selectivelyreflective optical element generally transmits the laser or BBL beamincident on the selectively reflective optical element, and alsoreflects to the imaging system at least a portion of the incident returnsignal received from the optical aperture. A device described herein canalso include an applicator attached to the distal end of the interiorchamber. The applicator is configured to couple the device to a surfaceof skin of a patient, including for laser or BBL beam delivery to thesurface of skin and/or imaging of the surface of skin, as describedfurther herein. Moreover, in some cases, a device described hereinfurther comprises one or more additional components, such as computerhardware and/or software for identifying a spatial location of one ormore structures or constituents of skin proximate the distal end of thedevice and/or for directing the laser or BBL beam to one or more desiredlocations on a surface of skin of a patient. Such hardware and/orsoftware can be used to control or actuate one or more additionalcomponents of a device described herein, such as one or more lenses,mirrors, and/or actuators.

Specific components of devices described herein will now be described infurther detail. Exemplary devices according to the present disclosureare also described in the specific Examples hereinbelow, including withreference to the drawings.

Turning now to specific components, devices described herein comprise aninterior compartment. The interior compartment can have any size andshape not inconsistent with the objectives of the present disclosure. Insome cases, the interior compartment defines, comprises, consists of,consists essentially of, or is an interior volume or region of ahandpiece. Such a handpiece can be a laser or BBL treatment handpieceincluding a proximal end or a grip portion or member for gripping by auser of the handpiece. A handpiece can also include a distal end or headportion or member from which a laser is directed toward a target, suchas a target treatment area described herein. Additionally, a handpiecedescribed herein, in some embodiments, is attached to one or moreadditional components of a light treatment system, such as a powersource. Moreover, a handpiece and/or interior compartment of a devicedescribed herein can be formed from any material not inconsistent withthe objectives of the present disclosure. For instance, in some cases,the handpiece and/or interior compartment is formed form a metal,plastic, a composite material (such as a fiber glass material), or acombination of two or more of the foregoing.

Devices described herein also comprise an optical aperture disposed atthe distal end of the interior compartment of a device described herein.An “optical aperture,” for reference purposes herein comprises anopening in the interior compartment that is used for the ingress and/oregress of light (such as laser light and/or light received from a targetarea for imaging purposes) into and/or from the interior compartment.However, as described further hereinbelow, it is to be understood thatan “optical” aperture can also be used for the ingress and/or egress ofother signals or waves, such as acoustic waves produced and/or receivedby an ultrasound transducer. The aperture can have any size or shape notinconsistent with the objectives of the present disclosure. In someinstances, the aperture has a size sufficiently large to allow a laseror BBL beam described herein to exit the interior compartment of thedevice and also sufficiently large to permit the receipt of light oranother return signal from a target area for imaging purposes, includingin a manner described herein. For example, in some cases, an opticalaperture or opening described herein has a size in one or two dimensions(e.g., a diametrical dimension, or length and width dimensions in aplane of the opening) of up to 5 cm, up to 3 cm, up to 2 cm, up to 1 cm,up to 0.5 cm, or up to 0.1 cm. Other dimensions are also possible.Further, in some embodiments, an optical aperture described herein has around or circular shape.

Additionally, devices described herein comprise a laser or BBL sourcepositioned or configured to produce a laser or BBL beam. It is to beunderstood that a “laser” can refer to a single lasing device thatproduces a single beam of laser light from a single lasing medium.Similarly, as understood by one of ordinary skill in the art, the terms“BBL” source and “BBL beam” can refer to a source and beam,respectively, of intense, broad-spectrum pulses of light, including asdefined and approved by the U.S. Food and Drug Administration. Moreparticularly, a BBL beam produced by a BBL source can comprise pulses ofnon-coherent or non-laser light having a wavelength from 500 nm to 1200nm, as described, for instance, in Raulin et al., “IPL technology: areview,” Lasers Surg. Med. 2003, 32:78-87. Any laser, BBL source, laserbeam, or BBL beam not inconsistent with the objectives of the presentdisclosure can be used. Moreover, the choice of laser, BBL source, orlaser or BBL beam can be based on a desired effect of the laser or BBLbeam and/or on a desired target of the laser or BBL beam. In some cases,for example, the beam is ablative, such as may be desired for destroyingor removing a target component or constituent of skin. Alternatively, inother embodiments, the beam is non-ablative. The beam may also becoagulative, where a “coagulative” beam is understood to causecoagulation of tissue in a target area described herein. Further, insome embodiments, the laser of a device described herein comprises ahybrid laser operable to produce laser beams having a plurality ofdiffering wavelengths. For instance, in some cases, the hybrid laser isoperable to selectively produce an ablative laser beam and a coagulativelaser beam. It is also possible to use both a BBL source and a laser inthe same device. Thus, in some embodiments, a single device describedherein can be used to produce and deliver one or more beams (e.g., oneor more laser beams, or one or more laser beams in combination with aBBL beam) having a range of properties, as needed for a specifictreatment or other application of the device.

A laser of a device described herein may also be a pulsed laser or acontinuous wave (CW) laser. Moreover, when a pulsed laser is used, thelaser can produce time-modulated pulses of the laser beam. For instance,in some cases, the laser beam comprises an ablative laser beam and thelaser produces time-modulated pulses of the ablative laser beam. Notintending to be bound by theory, it is believed that the use of such apulsed laser beam can provide both ablation and coagulation. Moreparticularly, in some embodiments, time-modulated pulses of an ablativelaser beam produce tissue ablation in an ablation area, followed bytissue coagulation around the ablation area.

A laser or laser beam of a device described herein can have any powerand any peak or average emission wavelength not inconsistent with theobjectives of the present disclosure. For example, in some embodiments,a laser or laser beam of a device described herein has a peak or averageemission wavelength in the infrared (IR) region of the electromagneticspectrum. In some such cases, the laser or laser beam has a peak oraverage emission wavelength in the range of 1-4 μm, 1-3 μm, 2-4 μm, 2-3μm, 8-12 μm, or 9-11 μm. For example, in some embodiments, the laser orlaser beam comprises an erbium-doped yttrium aluminum garnet (Er:YAG)laser or laser beam or a neodymium-doped YAG (Nd:YAG) laser or laserbeam having a peak or average emission wavelength of 2940 nm or 1064 nm.In other cases, the laser or laser beam comprises a carbon dioxide laseror laser beam. A laser beam described herein can also have a peak oraverage emission wavelength in the visible region of the electromagneticspectrum. Non-limiting examples of peak or average emission wavelengthssuitable for use in some embodiments described herein include 532 nm,695 nm, 755 nm, 1064 nm, and 1470 nm (e.g., for non-ablativeapplication), or 2940 nm (e.g., for ablative application). Further, insome instances, a laser or laser beam of a device described herein hasan average power of 1 to 100 W (e.g., when used for coagulation) or 5 to200 W (e.g., when used for ablation).

Moreover, the spot size of a laser beam produced by a laser describedherein may also vary. Any spot size not inconsistent with the objectivesof the present disclosure may be used. In some cases, for instance, thespot size is 0.1-10 mm, 0.1-1 mm, 0.1-0.5 mm, 0.5-5 mm, 1-10 mm, or 1-5mm. Other spot sizes may also be used.

A BBL source of a device described herein generally produces a pulsedlight output. In some cases, the BBL source comprises a xenon gas-filledchamber. In such instances, the BBL source can produce a BBL beam by theapplication of bursts or pulses of electrical current through thexenon-containing chamber.

It is further to be understood that the depth of tissue ablation,removal, or destruction performed by a laser or BBL source describedherein can vary. Any depth not inconsistent with the objectives of thepresent disclosure may be used. For example, in some embodiments, alaser or BBL ablation step removes at least 90%, at least 95%, at least98%, or at least 99% of tissue of a targeted skin component,constituent, or area to a depth of up to 1000 μm or to a depth of up to2000 μm. In some cases, an ablation step removes at least 90%, at least95%, at least 98%, or at least 99% of tissue of a targeted skincomponent, constituent, or area to a depth of 50-2000 μm, 50-1000 μm,50-500 μm, 50-300 μm, 50-200 μm, 75-500 μm, 100-2000 μm, 100-1000 μm,100-500 μm, 100-300 μm, 100-200 μm, 200-2000 μm, 200-1000 μm, 200-500μm, 400-2000 μm, 400-1000 μm, 500-2000 μm, 500-1000 μm, or 1000-2000 μm.Other depths are also possible, and the depth is not particularlylimited. Further, it is to be understood that “removing” tissue includesablating, vaporizing, destroying, and otherwise removing the tissue.

As described further herein, a laser or BBL beam produced by a laser orBBL source of a device described herein generally has an optical pathwithin the interior compartment of the device between the proximal endand the distal end of the device. Further, the optical path exits theinterior compartment through the optical aperture. The optical path canhave any length and/or shape not inconsistent with the objectives of thepresent disclosure, and the precise length and/or shape of the opticalpath is not particularly limited.

In some embodiments, a device described herein also comprises a lightsource other than the laser or BBL source described above. Inparticular, a device described herein can comprise a light source forilluminating an area or surface that is to be imaged and/or treated bythe device. Any light source not inconsistent with the objectives of thepresent disclosure may be used. For instance, in some cases, the lightsource comprises or is a non-laser light emitting diode or device (LED).The light source may also be an incandescent or fluorescent light bulb.Other light sources may also be used. Additionally, the light source ofa device described herein can be positioned or located on any portion ofthe device not inconsistent with the objectives of the presentdisclosure, provided that the light source is capable of illuminatingthe target area of the device. For example, in some embodiments, thelight source is positioned or located adjacent to the optical apertureof the device. Other locations of the light source are also possible.

Devices described herein further comprise an imaging system. Any imagingsystem not inconsistent with the objectives of the present disclosuremay be used. Additionally, in some embodiments, the imaging systemcomprises both a receiver module and also a query module. A “receivermodule,” for reference purposes herein, comprises one or more componentsconfigured or used to receive, detect; and/or process an imaging signal,such as a return signal described herein. A “query module,” forreference purposes herein, comprises one or more components configuredor used to produce or emit a query, diagnostic, probe, or pilot beamthat interacts with an imaging target and thereby produces a returnsignal from the imaging target, wherein the return signal can be used toimage the imaging target. Thus, in some cases, a receiver modulecomprises a return signal receiver, and a query module comprises a querybeam generator.

In some instances, the imaging system of a device described hereincomprises a camera. In some cases, the camera is positioned orconfigured to receive light from the optical aperture of the device.Such light can be the return signal of the imaging system. The light canhave a second average wavelength. Additionally, in some embodiments, thelight can have a second optical path within the interior compartment. Itis also possible, in some cases, for the camera to be positioned orconfigured to receive light from a target area without receiving lightthrough the optical aperture. For instance, in some cases, a camera of adevice described herein produces or records an image of a target areausing an optical path that is outside of the interior compartment of thedevice in which the first optical path of the laser or BBL beam islocated. In some instances, such a camera is placed or positionedoutside of the interior compartment of the device. For example, thecamera can be attached to an exterior portion of a handpiece or otherportion of a device described herein. In some such cases, the camera isdirected to receive light from and/or image a target area of a surfaceof skin (or other surface) that can be treated with a laser or BBL beamof the device in a manner described herein.

Any camera not inconsistent with the objectives of the presentdisclosure may be used, regardless of whether the camera is positionedto receive light and/or image a target area along an optical path withinan interior compartment of a device described herein, or outside of theinterior compartment. For example, in some cases, the camera comprises adigital camera capable of capturing, recording, and/or processingtwo-dimensional or three-dimensional images of a target area. Further, acamera described herein can be a visible light camera or an infraredcamera. Other cameras may also be used.

In other embodiments described herein, the imaging system comprises anoptical imaging system, such as an optical coherence tomography (OCT)system, a multi-photon imaging system, or a reflectance confocalmicroscopy (RCM) system. In such cases, the selectively reflectiveoptical element can be configured to reflect both an outgoing beam and areturn signal of the optical imaging system to permit the imaging systemto both “probe” a target area and also receive a return signal from thetarget area, including in a manner described herein. Additionally, asdescribed further herein, such an imaging system can comprise a querymodule and a receiving module. For instance, in the case of an OCTimaging system, the imaging system can comprise an OCT pilot or probingbeam generator and an OCT detector. The use of an OCT imaging system isespecially preferred in some embodiments in which imaging beneath thesurface of skin is needed or desired, such as to image a structure ofskin beneath the surface. An OCT or other imaging system describedherein can be used to image a component or structure of skin at anydepth not inconsistent with the objectives of the present disclosure.For example, in some cases, a skin component is imaged by the imagingsystem at a depth of up to 2 mm, up to 1 mm, or up to 0.5 mm.

In some embodiments, the imaging system of a device described hereincomprises an acoustic imaging system rather than an optical imagingsystem. For instance, in some cases, the imaging system is an ultrasoundimaging system. Such a system can comprise one or more ultrasoundtransducers and/or receivers. Additionally, when an acoustic imagingsystem such as ultrasound is used in a device described herein, it maynot be necessary to include a selectively reflective optical elementdescribed herein. Thus, in some cases, a device described hereincomprises a body comprising an interior compartment having a proximalend and a distal end, and an aperture disposed at the distal end of theinterior compartment. The device further comprises an imaging system,such as an acoustic imaging system, coupled to the body. The imagingsystem is configured to image a target area. The device also comprises alaser or Broad Band Light (BBL) source that produces a laser or BBLbeam, the laser or BBL beam having a first optical path within theinterior compartment between the proximal end and the distal end andexiting the interior compartment through the aperture. In addition, insome cases, the imaging system, which may be an ultrasound imagingsystem, receives a return signal from the aperture of the device. Insome cases, for example, the imaging system comprises an ultrasoundtransducer disposed in the interior compartment of the device.

Devices described herein, in some cases, also comprise a selectivelyreflective optical element disposed in the first optical path and in thesecond optical path, wherein the selectively reflective optical elementgenerally transmits the laser or BBL beam incident on the opticalelement. For example, in some cases, the selectively reflective opticalelement transmits at least 70% of the laser or BBL beam incident on theselectively reflective optical element, or is at least 70% transparentto the first average wavelength of the laser or BBL beam. Moreover, theselectively reflective optical element generally reflects a returnsignal to the imaging system or a portion thereof (such as a detector,receiver, or camera of the imaging system) from an imaged target areaand/or from an optical aperture of the device. For instance, in someembodiments, the selectively reflective optical element reflects to theimaging system at least 1% of the total intensity of incident lightreceived from an imaged area and/or optical aperture, or is at least 1%reflective to the second average wavelength of the light receivedthrough the optical aperture or otherwise received from the imaged area,which may be the targeted area. In some cases, the selectivelyreflective optical element has optical properties in accordance withTables I and II below.

TABLE I Percentage of Laser or BBL Beam Transmitted by SelectivelyReflective Optical Element or Percent Transparency of the SelectivelyReflective Optical Element to the Average or Peak Wavelength of theLaser or BBL Beam. Percent Transparency of Percentage of Laser OpticalElement to or BBL Beam Transmitted Laser or BBL Beam (based on totalincident intensity) (based on total incident intensity) ≥30% ≥30% ≥50%≥50% ≥60% ≥60% ≥70% ≥70% ≥75% ≥75% ≥80% ≥80% ≥85% ≥85% ≥90% ≥90% ≥95%≥95% ≥99% ≥99%

TABLE II Percentage of Return Signal from the Aperture or Imaged AreaReflected by Selectively Reflective Optical Element or PercentReflectance of the Selectively Reflective Optical Element to the Averageor Peak Wavelength of the Return Signal Received from the Aperture orImaged Area. Percentage of Light Reflected to Percent Reflectance ofImaging System Optical Element to Light (based on total incidentintensity) (based on total incident intensity) ≥0.1%  ≥0.1%   ≥1%  ≥1% ≥5%  ≥5% ≥10% ≥10% ≥20% ≥20% ≥30% ≥30% ≥40% ≥40% ≥50% ≥50% ≥60% ≥60%≥70% ≥70% ≥80% ≥80% ≥90% ≥90% ≥95% ≥95% 10-90%  10-90%  10-80%  10-80% 20-90%  20-90%  30-90%  30-90%  60-90%  60-90% 

Moreover, any selectively reflective optical element not inconsistentwith the objectives of the present disclosure may be used. Further, theoptical element can have any size, shape, and/or structure notinconsistent with the objectives of the present disclosure. In someembodiments, for instance, the selectively reflective optical elementcomprises or is a selectively reflective plate. In some embodiments, theselectively reflective optical element comprises a dichroic opticalelement or plate.

In addition, in some cases, a device described herein further comprisesan applicator. As described further herein, the applicator can be usedto connect or help position one or more components of a device describedherein relative to a surface that is targeted and/or treated by thedevice. For instance, in some cases, the applicator of a device helpsalign an optical aperture of the device with a target area of skin,including in a manner that permits precise imaging and/or laser or BBLtreatment of the target area or constituents or substructures present inthe target area. In some embodiments, a device described hereincomprises an applicator attached to the distal end of the interiorchamber, wherein the applicator is configured to couple, connect, orattach device to a surface of skin of a patient. Such an applicator canhave any structure or configuration not inconsistent with the objectivesof the present disclosure. For instance, in some cases, the applicatorcomprises a bottom surface adjacent to the surface of skin. The bottomsurface can be substantially flat or planar, such as may be the casewhen the bottom surface is formed from a rigid material such as a rigidplastic or metal material. The bottom surface may also be conformal tothe surface of skin, such as may be the case when the bottom surface isformed from a flexible or drapable material. Moreover, in someembodiments, the bottom surface comprises a window that is substantiallytransparent to the laser or BBL beam and/or to the light received by thecamera or other imaging system. A window that is “substantially”transparent to the laser or BBL beam and/or to the light received by thecamera or other imaging system can transmit at least 40%, at least 50%,at least 60%, at least 70%, at least 80%, at least 90%, or at least 95%of the laser or BBL beam and/or the light received by the camera orother imaging system, where the percent transmission can be based ontotal intensity of the laser or BBL beam and/or light received by thecamera or other imaging system that is incident on the window.Additionally, in some embodiments, the bottom surface of an applicatordescribed herein can have a cutout or gap that allows passage of a laseror BBL beam, illumination light, and/or camera light described herein.

Further, an applicator described herein can be reversibly attached to asurface of skin, of a patient (or to another surface). For instance, insome cases, the bottom surface of the applicator comprises or is coatedwith an adhesive for reversibly adhering the bottom surface of theapplicator to the surface of skin. Any adhesive not inconsistent withthe objectives of the present disclosure may be used. Non-limitingexamples of adhesives suitable for use in some embodiments describedherein include surgical adhesives such as those described in Duarte etal., “Surgical adhesives: Systematic review of the main types anddevelopment forecast,” Progress in Polymer Science, vol. 37, no. 8(2012), pages 1031-1050. Such adhesives may include natural orbiological adhesives, synthetic or semi-synthetic adhesives, andbiomimetic adhesives. In some embodiments, an adhesive described hereincomprises a cyanoacrylate adhesive such as a DERMABOND adhesive(available from Ethicon). In other instances, an applicator describedherein is reversibly attached to a surface of skin of a patient (or toanother surface) by a pressure differential or vacuum. For example, insome such cases, the applicator of a device described herein comprises anon-permeable chamber, and the bottom surface of the applicator formsone or more hermetic seals with the surface of skin. Additionally, thenon-permeable chamber of the applicator can be in fluid communicationwith a vacuum pump for supplying a vacuum to an interior of thenon-permeable chamber. In some such instances, the vacuum supplied tothe interior of the non-permeable chamber is strong enough to hold theapplicator in place, but not strong enough to readily cause bruising ofthe skin during a clinically relevant period of time. For example, insome embodiments, the vacuum supplied to the interior of thenon-permeable chamber is 0.10-0.40 atmospheres (atm) or 0.10-0.20 atm.

An applicator of a device described herein, in some cases, preventsrelative movement, or tracks relative movement, of the surface of skinof the patient in one or more lateral directions relative to the opticalaperture of the device. In this manner, an applicator described hereincan help ensure that a laser or BBL beam directed toward a target areaon the surface of skin is delivered precisely and accurately, includingunder clinical conditions in which a patient may be moving.

Devices described herein, in some embodiments, also comprise computerhardware and/or software for carrying out one or more diagnostic,imaging, and/or treatment steps described herein. Thus, in some cases, adevice described herein can be at least partially automated. Forexample, in some cases, a device is configured to carry out an imagingand/or treatment process according to instructions provided by acomputer as a function of space and/or time. The computer can include aprocessor and a memory storing computer-readable program code portionsthat, in response to execution by the processor, cause instructions tobe provided to one or more components of a device in a desired sequence.Any hardware and/or software not inconsistent with the objectives of thepresent disclosure may be incorporated into or used with a devicedescribed herein. Moreover, various suitable hardware and softwarecomponents will be readily apparent to those of ordinary skill in theart. Such hardware and/or software can also be used to carry out anystep or computational task not inconsistent with the objectives of thepresent disclosure. For instance, in some cases, a device comprisescomputer hardware and/or software for identifying a spatial location ofone or more constituents of skin proximate the distal end of the device,and/or treating the one or more constituents of skin followingidentification. The device may also comprise computer hardware and/orsoftware for identifying or determining a class or type, size, shape,color, estimated depth, and/or shaft angle of one or more skinconstituents. Further, the hardware and/or software can comprisesoftware for correcting and/or calibrating image non-linearities ordistortions from the second optical path or discrepancies in amechanical model used during image processing. Additionally, thecomputer hardware and/or software can be mechanically and electricallycoupled to the camera or other imaging system of the device, includingfor processing image data and/or transmitting the image data for furtherprocessing, presentation, or display. In some embodiments, computerhardware and/or software includes a controller coupled to one or morecomponents of the device, such as to the camera or other component of animaging system of the device. As described above, the camera or otherimaging system component can include an image recognition device ormodule that detects a component of skin (or a contrast agent associatedwith the skin component, as described further herein) and forms an imageof the labeled or unlabeled component of the skin. Computer hardwareand/or software of a device described herein can also include aprocessor configured to carry out one or more of the processes describedabove.

Moreover, computer hardware and/or software of a device described hereincan be used to direct the device to begin laser or BBL treatment (e.g.,ablation) at essentially “the same time” as theidentification/localization of target constituents or components isended. In other words, in some cases, imaging and treatment can occursequentially, from a clinical perspective. For instance, in some cases,the laser or BBL treatment is begun 1 minute or less, 30 seconds orless, 20 seconds or less, 10 seconds or less, 5 seconds or less, 1second or less, 0.5 seconds or less, or 0.1 seconds or less after theidentification/imaging is ended. It is also possible, in some cases, forthe laser or BBL treatment (e.g., laser ablation) to be carried outsimultaneously or nearly simultaneously with the imaging/identificationof target constituents, or partially temporally overlapping theimaging/identification. Thus, in some embodiments, a device describedherein enables rapid diagnosis (or imaging) and treatment of acondition, such as a skin condition, in a sequential or non-sequentialmanner.

Devices described herein can also comprise one or more additionalcomponents other than those described above. For instance, in somecases, a device described herein further comprises one or more lenses,mirrors, and/or actuators. Any such lenses, mirrors, and/or actuatorsnot inconsistent with the objectives of the present disclosure may beused. For example, in some embodiments, a device comprises one or morelenses, mirrors, and/or actuators for directing the light received fromthe optical aperture to the camera or other imaging system and/or fordirecting the laser or BBL beam to one or more desired locations on asurface of skin of a patient. Many suitable lenses, mirrors, actuators,or other hardware or software will be readily apparent to those ofordinary skill in the art.

It is further to be understood that a device described herein can haveany combination of properties or features described hereinabove notinconsistent with the objectives of the present disclosure.Additionally, as stated above, it should be further noted that devicesdescribed herein can also be used to provide laser or BBL source lightto surfaces or constituents or components of surfaces, or regions belowsurfaces, that may not be surfaces of skin of a human patient. Forexample, in some cases, a surface may be a surface of a non-biologicalmaterial, such as a metal surface or a polymeric surface.

Moreover, it is to be understood that systems comprising the foregoingdevices are contemplated herein. Such systems can further comprise oneor more components in addition to a device described herein. Forinstance, a system can also include a power source, an image displaydevice such as a screen or monitor, electrical cables and/or connectors,and/or one or more ergonomic structures for facilitating use of thedevice by a treatment provider such as a physician.

II. Methods of Treating Skin or a Component of Skin

In another aspect, methods of treating skin or a component, constituent,or structure of skin are described herein. It is to be understood thatsuch methods, in some cases, can be carried out using devices describedhereinabove in Section I. In some embodiments, for example, a method oftreating skin or a component of skin comprises removing, ablating,vaporizing, destroying, or otherwise treating the skin or component ofskin within a target area of a device described hereinabove in SectionI, including by directing a laser or BBL beam onto the skin or componentof skin from the device. Moreover, as described further herein, a methoddescribed herein can comprise labeling, imaging, detecting, and/ormapping the skin or component of skin prior to (or substantiallysimultaneously with) directing a laser or BBL beam onto the skin orcomponent of skin for treatment purposes. Alternatively, in otherinstances, the structure of skin is not labeled but is instead imaged ordetected in its “native” or natural state, without first labeling thestructure. It may be especially desirable to omit a labeling step whenthe relevant structure of skin is visually discernible, including in afacile manner, without the use of a labeling agent. Additionally, asdescribed further hereinbelow, a method described herein can bepartially or fully automated if desired, including for implementation bya computer.

Turning now more particularly to specific steps of methods describedherein, methods described herein comprise removing, ablating,vaporizing, destroying, or otherwise treating skin or a component,constituent, or structure of skin. Any component, constituent, orstructure of skin not inconsistent with the objectives of the presentdisclosure may be treated by a method described herein. For example, insome cases, the structure of skin is a pore, gland, hair follicle, acne,skin lesion (which may be benign, pre-malignant, or malignant), bloodvessel, or vascular lesion. Further, in some instances, the gland is aneccrine sweat gland, apocrine gland, or sebaceous gland. Other glandsmay also be targeted.

Methods described herein, in some embodiments, also comprise labeling acomponent, constituent, or structure of skin. Such labeling can becarried out in any manner not inconsistent with the objectives of thepresent disclosure. For example, in some cases, labeling comprisesapplying a contrast agent or dye to the structure of skin, which may bea pore or skin lesion. Labeling may also be carried out by marking witha pen or marker. Any contrast agent, dye, marker, or pen notinconsistent with the objectives of the present disclosure may be used.For instance, in some embodiments, the contrast agent is charged orionic. A contrast agent can also be an organic contrast agent or dye.One non-limiting example of a contrast agent that can be used in amethod described herein includes methylene blue. Other contrast agentsmay also be used. In addition, in some cases, applying a contrast agentto the structure of skin comprises applying a composition (such as asolution, cream, or paste) containing the contrast agent to the surfaceof the skin. Moreover, in some embodiments, a contrast agent is appliedto the structure of the skin electrophoretically or using iontophoresis.For instance, in some cases, the contrast agent is delivered through thelocal application of an electrical current to the skin. The use of anelectrical current or voltage may be especially preferred for labelingpores with a contrast agent such as methylene blue. Specific components,constituents, or structures of skin may be labeled in other manners aswell, as understood by one of ordinary skill in the art.

Methods described herein also comprise directing or applyingelectromagnetic radiation to skin or a specific component, constituent,or structure of skin. Electromagnetic radiation can be applied to skinor a component, constituent, or structure of skin in any manner notinconsistent with the objectives of the present disclosure. For example,in some cases, the electromagnetic radiation is a laser or BBL beamproduced by a device described in Section I hereinabove. Any such laseror BBL beam not inconsistent with the objectives of the presentdisclosure may be used. For example, in some cases, the electromagneticradiation is applied by a laser or BBL source coupled to a camera (orother imaging system) and a controller.

More generally, various steps of a method described herein, in additionto the step of applying a laser or BBL beam to skin, or to a componentor constituent of skin, can be carried out using a computer. Thus, insome embodiments, computer-implemented methods are described herein. Insome cases, such a method is for identifying and determiningcharacteristics of skin constituents so as to guide the appropriatedelivery of therapeutic laser or BBL energy. In some instances, such amethod comprises capturing one or more images with at least one camera(such as a digital camera described hereinabove) or other imagingsystem. If a camera is used, the camera can have a fixed or unvaryingfocal length. Additionally, if a plurality of cameras is used, eachcamera can have a fixed focal length, though the fixed focal lengths ofthe plurality of cameras can vary from one another. A method describedherein can further comprise compensating for one or more opticaldistortions of the optical path of the camera or other imaging systemcomponent that may be present. In some cases, the method also comprisescropping one or more of the one or more images, as needed or desired,and retaining only the portion of any cropped images that is relevant totherapy performed by the method. In some embodiments, the method furthercomprises identifying therapeutically pertinent skin constituents. Suchconstituents, in some instances, are identified by their spatiallocation, size, color, estimated depth beneath the surface of the skin,and/or estimated angle of shaft, in the event there is a shaft. A methoddescribed herein can further comprise mapping skin constituents and/orskin constituent characteristics (e.g., location) to a mechanical modelof a positioning system of the laser or BBL source, such that theposition of the laser or BBL source (and/or a laser or BBL beam providedby the laser or BBL source) is known relative to the position of therelevant skin constituents. Such a method can further comprisetransmitting the skin constituent characteristics (e.g., location) to acontroller of the laser or BBL source so that a laser or BBL beam can bedirected to one or more skin constituents as desired by a user. It is tobe understood that one or more of the foregoing steps of acomputer-implemented method can be carried out using hardwareand/software described herein.

In addition, a method described herein can include placing one or moreportions of a device described herein in direct contact with skin or asurface of skin to be imaged and/or treated. For example, in someinstances, the bottom surface of an applicator described herein isplaced in direct contact with the skin or surface of skin. In othercases, the aperture of the device and/or a component of the imagingsystem is placed in directed contact with the skin or surface of skin.

As described above, methods described herein can be used to treat avariety of skin components, constituents, or structures, including toameliorate a variety of skin conditions or other conditions in a humanpatient in need thereof. It is to be understood that the skin treated bya method described herein can be located on any region of the body ofthe patient not inconsistent with the objectives of the presentdisclosure. For example, in some cases, the treatment area of the skinis within the axillae, sole or palm. The foregoing regions of the bodymay be particularly suitable for the treatment of hyperhidrosis. Thus,in some embodiments, a method of treating hyperhidrosis is describedherein.

Some embodiments described herein are further illustrated in thefollowing non-limiting examples.

EXAMPLE 1 Devices for Laser Treatment of Skin

Exemplary devices for laser treatment of skin according to someembodiments described herein are further described with reference to thedrawings.

FIGS. 1, 2A, and 2B illustrate various aspects of a device for the lasertreatment of skin. Referring to FIG. 1, a device, generally designated100, for the image-guided laser treatment of different skin conditionsis shown. Treatment of skin conditions can include, but is not limitedto, sweat gland treatment and/or removal, hair treatment and/or removal,acne treatment and/or ablation, pigmented lesion treatment, vascularlesion treatment, skin cancer treatment and/or ablation, blood vesseltreatment and/or removal, capillary treatment and/or removal, etc.Notably, device 100 is configured to laser treat precisely targetedareas of a patient's skin, where the precisely targeted areas aredetermined and/or identified via an image analysis system including acamera operating in the visible or infrared portions of theelectromagnetic spectrum.

As FIG. 1 illustrates, device 100 includes an interior compartment 102having a proximal end 102A (e.g., proximal to a user), a distal end102B, and an optical aperture 104 disposed at and/or proximate to thedistal end 102B. Device 100 is a handheld device configured to begrasped by a user (e.g., doctor, nurse, surgeon, medical practitioner,medical professional, etc.) during a laser therapy procedure to treatone or more lesions and/or constituents disposed on a patient's skin S.For example and during use, optical aperture 104 can be aimed by theuser and face a surface of the patient's skin S to be treated.

A laser 106 can also be provided, disposed, and/or otherwise housedwithin a portion of interior compartment 102, for example, between thedistal and proximal ends 102A, 102B. However, it is to be understoodthat laser 106 can be located inside or outside the interior compartment102, or can be part of a system comprising the device 100, rather thanbeing located within device 100 itself. In the event the laser 106 islocated outside of the interior compartment 102 or the device 100, laser106 is optically coupled to the device 100 and/or interior compartment102. The skin S facing device 100 may include, without limitation, skinof the axillae, sole or palm. Such skin S may include one or moreconstituents (e.g., a hair, a pore, sweat gland, pigmented skin cell,blood vessel, vascular lesion, skin cancer, etc.) to be treated,removed, and/or ablated.

Laser 106 produces, or is positioned and/or configured to produce, alaser beam 106A of a first average wavelength. The first averagewavelength is from about 100-12,000 nm or 600-12,000 nm, or any subrangetherebetween (e.g., 600-800 nm, 1100-1400 nm, 1300-1500 nm, 1400-1600nm, 2000-3000 nm, 2750-2950 nm, 9,000-11,000 nm, etc.), for example,depending upon whether the laser beam is ablative or non-ablative.

In certain embodiments, laser 106 produces a laser beam having a firstaverage wavelength about 532 nm, about 694 nm, about 755 nm, about 1064nm, about 1470 nm, about 1320 nm, about 1440 nm, about 1450 nm, about1550 nm, about 2790 nm, about 2940 nm, or about 10,600 nm. Laser 106 cancomprise an Erbium-based laser (e.g., an Er:YAG laser), a carbon dioxide(CO₂) laser, a Thulium (Tm) laser, a Neodymium-based laser (e.g., aNd:YAG laser), or a combination thereof. As persons having skill in theart will appreciate, laser 106 can comprise any type of laser that issuitable for the non-invasive, ablative or non-ablative therapeutictreatment skin S consistent with the objectives of the instantdisclosure, including but not limited to selective photothermolysisprocedures.

As FIG. 1 further illustrates, laser beam 106A has a first optical path(i.e., shown in the uniform dashed line), which extends through and/oralong a length of interior compartment 102. The first optical pathextends between the respective proximal and distal ends 102A, 102B, andexits interior compartment 102 through optical aperture 104 towards skinS. Laser beam 106A can treat the patient's skin S via contacting and/orpenetrating one or more layers thereof.

Device 100 can further comprise a camera 108. Camera 108 can bepositioned or configured to receive light 108A of a second averagewavelength from the optical aperture 104. In some embodiments, a lightsource LS can emit light towards the surface of the subject's skin S,and the light can be reflected off the skin back up through aperture 104and received at camera 108. For example and in some embodiments, light108A from the skin S is reflected through the aperture 104 and routed tothe camera 108 via one or more optical elements (e.g., mirrors, lenses,dichroic filters, plates, etc.). The light 108A traverses a secondoptical path (i.e., shown in the dashed line consisting of short dashes)within interior compartment 102 between skin S and camera 108. Light108A can have a second average wavelength of light that is, for exampleand without limitation, in the visible or infrared portions of theelectromagnetic spectrum. For example, the second average wavelength oflight can be from about 390 nm to 700 nm, or a subrange thereof (e.g.,450-520 nm, 520-620 nm, 600-700 nm, etc.) or from about 700 nm to 1 mm,or a subrange thereof (e.g., 700 nm-1050 nm, 1000 nm-2000 nm,10000-50000 nm, etc.).

One or more optical elements are disposed and/or housed within interiorcompartment 102. For example, at least a first optical element 110 isdisposed in interior compartment 102 between respective distal andproximal ends 102A, 102B. In certain embodiments, first optical element110 comprises a selectively reflective plate that is placed, positioned,or disposed in the first and second optical paths. First optical element110 is selectively reflective, meaning it can reflect some light (i.e.,some wavelengths in the electromagnetic spectrum) and transmit otherlight (i.e., some other wavelengths in the electromagnetic spectrum).

For example and in some embodiments, at least about 70% of the totalintensity of the laser beam 106A incident on the selectively reflectiveoptical element 110 is transmitted. That is, first optical element 110is at least 70% transparent to the first average wavelength of lightassociated with the laser beam 106A. Further, the selectively reflectiveoptical element 110 reflects light 108A to the camera 108, and at least1% of the total intensity of incident light 108A received from theoptical aperture 104 is reflected and aimed towards camera 108. That is,first optical element 110 is at least 1% reflective of the secondaverage wavelength of light 108A. Thus, first optical element 110 isselectively reflective, meaning it is reflective of the second averagewavelength of light 108A, while simultaneously transmissive to the firstaverage wavelength of light emitted associated with laser beam 106A.

In certain embodiments, first optical element 110 comprises asemi-reflective or dichroic plate disposed in the device 100 thatadvantageously combines laser delivery with imaging, as the plate ispartially or fully transparent to the laser light (i.e., 106A) andpartially or fully reflective of the imaging wavelength (i.e., light108A). Laser beam 106A can pass through first optical element 110 and bedelivered to a target area on the skin S, while the image reflected fromthe skin S as it passes through aperture 104 is reflected from firstoptical element 110 towards and/or to camera 108.

Device 100 can further comprise one or more additional optical elementsdisposed in interior compartment 102, including but not limited to oneor more lenses, mirrors, and/or actuators for directing the lightreceived from optical aperture 104 to camera 108 and/or for directinglaser beam 106A to one or more desired locations on a patient's skin S.For example, at least a second optical element 112 can be disposedproximate distal end 102B of device 100 and opposite from the firstoptical element 110. Second optical element 112 can comprise areflective plate or mirror that is fully or substantially fullyreflective of light 108A and laser beam 106A. For example, secondoptical element 112 can reflect laser beam 106A towards skin S andreflect light 108A towards camera 108.

Still referring to FIG. 1 and in some embodiments, device 100 furthercomprises an applicator 114 attached to the distal end 102A of interiorcompartment 102. Applicator 114 may attach to and/or extend from aportion of aperture 104 and/or optionally be at least partially receivedtherein. Applicator 114 is configured to couple, connect, or attachdevice 100 to a surface of the patient's skin S to facilitate treatmentof a certain area of the patient's skin. Applicator 114 can connect todevice 100 via a connecting portion or member 115. Connecting member 115can comprise a leg disposed on one side of applicator 114, or acircular, cylindrical, and/or conical member that surrounds portions ofthe optical actuator 104 to aim and/or contain laser beam 106A.

In some embodiments, applicator 114 can comprise or be formed of metal,plastic, or combinations thereof and conform to portions of thepatient's skin S during use. For example, applicator 114 can define animaging area A on the skin S as a bottom surface 116 of applicatorcontacts the skin S. The bottom surface 116 of applicator 114 cancomprise a window (FIGS. 2A, 2B) by which an affected portion P of skinis viewed and/or imaged. An image I of the affected portion P of thepatient's skin is transmitted to camera 108 and displayed on a display118. Notably, device 100 combines imaging and laser techniques fortherapeutically treating specific constituents on a patient's skin viaan easily manipulated hand held device. Device 100 includes and/or isconnected to a computing platform CP comprising computer hardware and/orexecuting computing software for identifying a spatial location of oneor more constituents in affected portion P of skin S proximate thedistal end of the device.

FIGS. 2A and 2B are respective plan and sectional views of deviceapplicator 114. FIG. 2A is a plan view of bottom surface 116 ofapplicator 114. Bottom surface 116 is configured to be positionedadjacent and/or in contact with a patient's skin (i.e., S, FIG. 1), andover, on, and/or around an affected area or portion (i.e., P, FIG. 1)thereof, which contains one or more constituents to be imaged andtargeted for laser application. Applicator 114 connects to device 100via connecting member 115.

Referring collectively FIGS. 2A and 2B, bottom surface 116 comprises awindow 120 that is substantially transparent to both the laser beam(i.e., 106A, FIG. 1) and light (i.e., 108A, FIG. 1) received by thecamera. An affected area or portion (e.g., P, FIG. 1) of the patient'sskin can be aligned and disposed in window 120 during treatment, so thatthe affected area can be imaged and displayed on a screen forfacilitating precisely targeted laser therapy applied to specificconstituents (e.g., hair follicles, pores, pigmented skin cells,abnormal skin cells, sweat glands, etc.) of the affected area. Bottomsurface 116 can be substantially flat and/or planar, but also configuredto conform to a surface of the patient's skin during use.

In some embodiments, an adhesive is applied to bottom surface 116 ofdevice 100 for temporarily and/or reversibly adhering the bottom surface116 of applicator 114 to the patient's skin during treatment. This canminimize movement of the device, skin, and/or otherwise stabilizeapplicator 114 during treatment. An exemplary adhesive comprisescyanoacrylate.

In further embodiments, applicator 114 comprises a non-permeable chamber122 that, upon application of a vacuum, causes portions 124 of bottomsurface 116 to form one or more hermetic seals with the surface of theskin. That is, when a vacuum is applied, portions 124 of bottom surface116 can hermetically seal to or against the skin's surface for improvedtargeting and stabilization during a laser therapy procedure. Chamber122 can be in fluid communication with a vacuum pump (not shown) via afitting 126 for establishing a vacuum within the interior ofnon-permeable chamber 122.

As applicator 114 is brought into contact with the skin, the device isaligned so that target skin constituents (i.e., in portion P, FIG. 1)are visible through applicator window 120 and displayed on a screen forapplication of targeted laser therapy. Then, in certain embodiments, avacuum pump connected to chamber 122 fitting 126 is activated forsealing applicator 114 to the patient's skin. The vacuum level inchamber 122 can provide firm attachment of the applicator to the skin,and at the same time be comfortable enough for the patient. In someembodiments, a vacuum of about 10-40% or 10-20% of the atmosphericpressure is applied to chamber 120, where desired.

EXAMPLE 2 Systems for Laser or BBL Treating Skin

FIG. 3 is a block diagram of an exemplary system, generally designated300, for laser or BBL treating skin. System 300 can comprise animage-guided laser or BBL treatment device 302 and a controller 304. Itis understood that controller 304 is a special purpose computerconfigured to improve the technological field of imaging and lighttherapy treatments. Such improvements are manifested in terms ofimproved targeting and light treatment of individual skin constituents(e.g., individual skin cells, cancer cells, pigmented cells, individualpigmented lesions, individual pores, individual sweat glands, etc.). AsFIG. 3 illustrates, device 302 and controller 304 can be separate (e.g.,physically separate, non-integrated, discrete) entities or components.However, a system comprised of a device 302 that is integrated with acontroller 304 is also contemplated.

Device 302 can comprise an imaging system (IS) 306 and a treatmentsystem (TS) 308. Notably, IS 306 and TS 308 can collectively improve thetargeting and treatment of discrete (i.e., individualized) skinconstituents (e.g., sweat glands, pores, pigmented lesions, etc.),without having a significant effect on the skin that surrounds thediscrete skin constituents.

In some embodiments, IS 306 is a camera (e.g., a digital camera) forimaging the skin and TS 308 is a laser or BBL source (e.g., a CO₂ laser,Er:YAG laser, etc.) for treating the skin. In other embodiments, IS 306is an OCT imaging system, an ultrasound imaging system including anultrasound transducer, or a multiphoton imaging system. As describedabove, imaging system 306 may include any type of imaging system notinconsistent with the objectives of the instant disclosure. Imagingsystem 306 may be non-invasive and may image a surface of skin or aregion beneath the surface of the skin.

Device 302 is moved or guided relative to the patient's skin accordingto instructions received from controller 304. As device 302 moves,controller 304 instructs TS 308 to generate a laser or BBL beam, thatdevice 302 can direct, treat and apply to individual skin constituents(e.g., sweat glands, pores, pigmented lesions, etc.). The instructionsreceived at device 302 from controller 304 are formulated from imagingdata 310 that is collected and/or received via IS 306 and thencommunicated and processed at controller 304. IS 306 collects orcaptures imaging data 310 and then sends the imaging data 310 tocontroller 304. Device 302 and controller 304 can electricallycommunicate using either a wired or wireless connection. Imaging data310 can include, for example and without limitation, digital data thatis representative of the presence and/or spatial locations of labeledskin constituents relative to the areas or locations of non-labeledskin.

Controller 304 is configured to receive, as input, imaging data 310 andconstruct a digitized map of the labeled skin conditions. For example,controller 304 can comprise a processor 312 configured to execute afeature recognition module 316 stored in the memory 314 of controller316. Feature recognition module 316 is configured to input imaging data310 and construct a digitized map of the labeled skin constituentsrelative to the area of skin to be treated. The locations of the mappedconstituents correspond to coordinates that identify points for laser orBBL ablation and/or laser or BBL treatment allowing for improved,targeted treatment of individually mapped skin constituents.

Controller 304 can output (e.g., via a wired or wireless connection)control signals or commands instructing device 302 to move to positionsor locations relative to the patient's skin that are centered over oneof the desired coordinates corresponding to a labeled skin constituent.Once device 302 is in a desired position, controller 304 can outputcontrol signals or commands instructing TS 308 to generate a laser orBBL beam to individually treat such constituents via ablative ornon-ablative light therapy.

As FIG. 3 illustrates, the subject matter described herein can beimplemented in software in combination with hardware and/or firmware.For example, the subject matter described herein can be implemented insoftware executed by a processor. As used herein, the terms “function”and “module” refer to hardware, firmware, or software in combinationwith hardware and/or firmware for implementing features describedherein. In an exemplary implementation, the subject matter describedherein can be implemented using a non-transitory computer readablemedium having stored thereon computer executable instructions that whenexecuted by the processor of a computer control the computer to performsteps. Exemplary computer readable media suitable for implementing thesubject matter described herein include non-transitory computer-readablemedia, such as disk memory devices, chip memory devices, programmablelogic devices, and application specific integrated circuits. Inaddition, a computer readable medium that implements the subject matterdescribed herein may be located on a single device or computing platformor may be distributed across multiple devices or computing platforms.

EXAMPLE 3 Devices for Light Treatment of Skin

FIG. 4 illustrates various aspects of a further embodiment of a devicefor the light treatment of skin. Referring to FIG. 4, a device,generally designated 400, for the image-guided light treatment ofdifferent skin conditions is shown. Treatment of skin conditions caninclude, but is not limited to, sweat gland treatment and/or removal,hair treatment and/or removal, acne treatment and/or ablation, pigmentedlesion treatment, vascular lesion treatment, skin cancer treatmentand/or ablation, blood vessel treatment and/or removal, capillarytreatment and/or removal, etc.

Notably, device 400 is configured to treat precisely targeted areas of apatient's skin, where the precisely targeted areas are determined and/oridentified via an imaging system that may include, without limitation,an OCT imaging system or a multiphoton imaging system. Any imagingsource not inconsistent with the objectives of the present disclosuremay be used to generate or capture image data.

As FIG. 4 illustrates, device 400 includes an interior compartment 402having a proximal end 402A (e.g., proximal to a user), a distal end402B, and an optical aperture 404 disposed at and/or proximate to thedistal end 402B. Device 400 can include a handheld device configured tobe grasped by a user (e.g., doctor, nurse, surgeon, medicalpractitioner, medical professional, etc.) during a laser therapyprocedure to treat one or more lesions and/or skin constituents disposedon a patient's skin S. For example and during use, optical aperture 404can be aimed by the user and face a surface of the patient's skin S tobe imaged and treated.

A laser or BBL source 406 can also be provided, disposed, and/orotherwise housed within a portion of interior compartment 402, forexample, between the distal and proximal ends 402A, 402B. The skin Sfacing device 400 may include, without limitation, skin of the axillae,sole or palm. Such skin S may include one or more constituents (e.g., ahair, a pore, sweat gland, pigmented skin cell, blood vessel, vascularlesion, etc.) to be treated, removed, and/or ablated.

Laser or BBL source 406 produces, or is positioned and/or configured toproduce, a treatment beam 406A having a first optical path. Thetreatment beam may be ablative or non-ablative. As persons having skillin the art will appreciate, laser or BBL source 406 can comprise anytype of laser or therapy source that is suitable for the non-invasive,ablative or non-ablative therapeutic treatment skin S consistent withthe objectives of the instant disclosure, including but not limited toselective photothermolysis procedures.

As FIG. 4 further illustrates, laser beam 406A has a first optical path(i.e., shown in the uniform dashed line), which extends through and/oralong a length of interior compartment 402. The first optical pathextends between the respective proximal and distal ends 402A, 402B, andexits interior compartment 402 through optical aperture 404 towards skinS. Treatment beam 406A can treat the patient's skin S via contactingand/or penetrating one or more layers thereof.

Device 400 can further comprise an imaging system 408. Imaging system408 can comprise an OCT imaging system, an ultrasound imaging systemincluding an ultrasound probe (not shown) or a multiphoton imagingsource. Imaging system 408 images the skin via a diagnostic, forwardbeam, probe, pilot, or query beam or signal, and via a return signal. Asschematically illustrated in FIG. 4, the query beam and the returnsignal collectively form a bidirectional signal 408A having a secondoptical path. An optional light source LS can be provided to assist inthe imaging process if desired.

In certain embodiments, imaging system 408 includes a query beamgenerator configured to generate a query beam. The query beam mayinclude an OCT pilot beam or signal. Imaging system 408 can alsocomprise a receiver that receives the return signal traversing thesecond optical path and stores the aspects of the return signal asimaging data. For example and in some embodiments, signals from the skinS are received by the aperture 404 and routed to the imaging system 408.

In certain embodiments, one or more optical elements (e.g., mirrors,lenses, dichroic filters, plates, etc.) are also disposed in device 400.Such optical elements are optional depending upon the imaging system408. For example, where imaging system 408 comprises a camera or OCTsource, optical elements may be provided to route imaging data thereto.Where imaging system 408 comprises an ultrasound probe, such optics maynot be needed.

Where used, such optics may include at least a first optical element 410disposed in interior compartment 402 between respective distal andproximal ends 402A, 402B. In certain embodiments, first optical element410 comprises a selectively reflective plate that is placed, positioned,or disposed in the first and second optical paths. First optical element410 is selectively reflective, meaning it can reflect some light (i.e.,some wavelengths in the electromagnetic spectrum) and transmit otherlight (i.e., some other wavelengths in the electromagnetic spectrum).Device 400 can further comprise one or more additional optical elementsdisposed in interior compartment 402, including but not limited to oneor more lenses, mirrors, and/or actuators for directing the lightreceived from optical aperture 404 to imaging system 408 and/or fordirecting laser beam 406A to one or more desired locations on apatient's skin S. For example, a second optical element 412 canoptionally be disposed proximate distal end 402B of device 400, wheredesired.

Still referring to FIG. 4 and in some embodiments, device 400 furthercomprises an applicator 414 attached to the distal end 402A of interiorcompartment 402. Applicator 414 may attach to and/or extend from aportion of aperture 404 and/or optionally be at least partially receivedtherein. Applicator 414 is configured to couple, connect, or attachdevice 400 to a surface of the patient's skin S to facilitate treatmentof a certain area of the patient's skin. Applicator 414 can connect todevice 400 proximate aperture 404.

Notably, device 400 combines imaging and treatment sources fortherapeutically treating specific constituents on a patient's skin viaan easily manipulated hand held device. Device 400 includes and/or isconnected to a controller comprising computer hardware and/or executingcomputing software for identifying a spatial location of one or moreconstituents in an affected portion P of skin S proximate the distal endof device 400.

The invention claimed is:
 1. A device for light treatment of skin, thedevice comprising: a handpiece comprising an interior compartment havinga proximal end and a distal end; an optical aperture disposed at thedistal end; a laser or Broad Band Light (BBL) source that produces alaser or BBL beam, the laser or BBL beam having a first optical pathwithin the interior compartment between the proximal end and the distalend and exiting the interior compartment through the optical aperture;an imaging system that receives a return signal from the opticalaperture, the return signal having a second optical path within theinterior compartment; a selectively reflective optical element disposedin the first optical path and in the second optical path, and anapplicator attached to the distal end of the interior chamber, whereinthe applicator couples the device to a surface of skin of a patient,wherein the selectively reflective optical element transmits at least60% of the laser or BBL beam incident on the selectively reflectiveoptical element, wherein the selectively reflective optical elementreflects to the imaging system at least 1% of incident light receivedfrom the optical aperture, and wherein the applicator prevents relativemovement of the surface of skin of the patient in one or more lateraldirections relative to the optical aperture, and wherein the laser orBBL beam has a peak or average emission wavelength in the visible orinfrared (IR) region of the electromagnetic spectrum, and wherein thelaser or BBL beam is non-ablative.
 2. The device of claim 1, wherein theapplicator comprises a bottom surface adapted to be placed adjacent tothe surface of skin.
 3. The device of claim 2, wherein the bottomsurface comprises a window that is substantially transparent to thelaser or BBL beam and to the light received by the imaging system. 4.The device of claim 2, wherein the applicator comprises a non-permeablechamber and the bottom surface of the applicator forms one or morehermetic seals with the surface of skin.
 5. The device of claim 4,wherein the non-permeable chamber of the applicator is in fluidcommunication with a vacuum pump for supplying a vacuum to an interiorof the non-permeable chamber.
 6. The device of claim 5, wherein thevacuum supplied to the interior of the non-permeable chamber is0.10-0.40 atmospheres.
 7. The device of claim 1 further comprisingcomputer hardware and/or software for identifying a spatial location ofone or more constituents of skin proximate the distal end of the device.8. The device of claim 7, wherein the computer hardware and/or softwareis mechanically and electrically coupled to the imaging system.
 9. Thedevice of claim 1 further comprising computer hardware and/or softwarefor identifying a class, size, shape, color, estimated depth, or shaftangle of one or more constituents of skin proximate the distal end ofthe device.
 10. The device of claim 1 further comprising computerhardware and/or software for correcting and/or calibrating imagenon-linearities or distortions from the second optical path ordiscrepancies in a mechanical model used during image processing. 11.The device of claim 1 further comprising one or more lenses, mirrors,and/or actuators for directing the return signal received from theoptical aperture to the imaging system and/or for directing the laser orBBL beam to one or more desired locations on a surface of skin of apatient.
 12. The device of claim 1, wherein the laser is an Er:YAGlaser.
 13. The device of claim 1, wherein the laser comprises a hybridlaser operable to produce laser beams having a plurality of differingwavelengths.
 14. The device of claim 1, wherein the imaging systemcomprises a multi-photon imaging system or a reflectance confocalmicroscopy (RCM) system.
 15. The device of claim 1, wherein the imagingsystem comprises a query beam generator and a return signal receiver.16. The device of claim 1, wherein the laser is a pulsed laser.
 17. Thedevice of claim 1, wherein the imaging system is an optical coherencetomography (OCT) imaging system.
 18. A device for light treatment ofskin, the device comprising: a body having an interior compartment, theinterior compartment having a proximal end and a distal end; an aperturedisposed at the distal end; an acoustic imaging system coupled to thebody and configured to image a target area; a laser or Intense PulsedLight (BBL) source that produces a laser or BBL beam, the laser or BBLbeam having a first optical path within the interior compartment betweenthe proximal end and the distal end and exiting the interior compartmentthrough the optical aperture; and an applicator attached to the distalend of the interior compartment, wherein the applicator couples thedevice to a surface of skin of a patient and prevents relative movementof the surface of skin in one or more lateral direction relative to theaperture, wherein the laser or BBL beam has a peak or average emissionwavelength in the visible or infrared (IR) region of the electromagneticspectrum, and wherein the laser or BBL beam is non-ablative.
 19. Adevice for light treatment of skin, the device comprising: a handpiececomprising an interior compartment having a proximal end and a distalend; an optical aperture disposed at the distal end; a laser or BroadBand Light (BBL) source that produces a laser or BBL beam, the laser orBBL beam having a first optical path within the interior compartmentbetween the proximal end and the distal end and exiting the interiorcompartment through the optical aperture; an imaging system thatreceives a return signal from the optical aperture, the return signalhaving a second optical path within the interior compartment; aselectively reflective optical element disposed in the first opticalpath and in the second optical path, and an applicator attached to thedistal end of the interior chamber, wherein the applicator couples thedevice to a surface of skin of a patient, wherein the selectivelyreflective optical element transmits at least 60% of the laser or BBLbeam incident on the selectively reflective optical element, wherein theselectively reflective optical element reflects to the imaging system atleast 1% of incident light received from the optical aperture, andwherein the applicator prevents relative movement of the surface of skinof the patient in one or more lateral directions relative to the opticalaperture, and wherein the laser or BBL beam has a peak or averageemission wavelength in the visible or infrared (IR) region of theelectromagnetic spectrum, wherein the laser or BBL beam is ablative.